Delivery tube assembly for an applicator

ABSTRACT

A delivery tube assembly is provided, the delivery tube assembly including a delivery tube including a delivery tube attachment end, an open delivery tube second end opposite the delivery tube attachment end, an outer surface, and an inner surface defining a delivery tube cavity; and a dosage form including a therapeutic agent, wherein the dosage form is positioned within the delivery tube cavity. The assembly may also include an engagement mechanism positioned at the delivery tube attachment end. The assembly may also include a containment seal coupled to the delivery tube second end. The assembly may also include an inner containment seal positioned within the delivery tube cavity to seal the dosage form within the delivery tube cavity.

BACKGROUND

This invention pertains to delivery devices used for the application ofvarious therapeutic treatments or other non-medicinal preparations intothe vaginal or other cavity and methods of providing such devices.

Many disease states and physiological conditions may occur in a woman,including symptoms associated with premenstrual syndrome, menstruation,and menopause. These symptoms may include dysmenorrhea (menstrualcramping), irritability, water retention, moodiness, depression,anxiety, skin changes, headaches, breast tenderness, tension, weightgain, cravings, fatigue, hot flashes, itching, and other associatedsensory maladies.

Many of these symptoms are due to changes in hormonal levels throughoutthe menstrual cycle. One example that affects a large number ofpost-pubescent women is dysmenorrhea, which is the occurrence of painfuluterine cramps during menstruation. Menstrual cramping is associatedwith increased levels of prostaglandin F2α, prostaglandin E2, and, insome cases, leukotrienes in the endometrium and menstrual fluid. Theseeicosinoids lead to restricted blood flow to the uterus and increaseduterine contractions, causing pain.

Various analgesics may be effective in limiting the pain fromdysmenorrhea; however some orally-delivered analgesics can cause nauseaand vomiting or other untoward side effects; therefore alternativeroutes of analgesic delivery are of interest.

Attempts have been made to deliver analgesics in the vicinity of thecervix and the vaginal mucosa using various vaginally-inserted devicesand methods. Because many of these symptoms typically occur inconjunction with menstruation, some have tried to combine an analgesicwith a tampon by coating the tampon, dipping the tampon, or by combiningthe analgesic with the tampon materials.

For example, in a method of preparation of such a product appropriatefor a laboratory setting, a formulation of a fatty compound excipientand an analgesic are heated to a liquid state. Constant mixing of theheated formulation is required to produce a homogeneous formulation. Theformulation is then poured onto the tip of a tampon held in a form tocontain the liquid. As the formulation cools, the ingredients solidifyinto a solid waxy substance that has adhered to the absorbent materialof the tampon and is thereby securely fastened to the tip of the tampon.

SUMMARY OF THE INVENTION

Several problems are inherent in a process that attempts to introduce aformulation including a therapeutic agent into or onto a tampon bycoating, dipping, solidifying, or the like. Processes such as these maywork in a laboratory setting but may not be feasible within an automatedtampon manufacturing process. Because of dosing requirements, theformulation including a therapeutic agent must be maintained in asolution that is both homogeneous and of the proper purity to ensureconsistent concentration of the therapeutic agent. These requirementsare difficult to accomplish during production operation of an automatedtampon manufacturing process, and are significantly more difficult tomaintain when the automated tampon manufacturing process stops. Inaddition, different styles and sizes of tampons may have differentdensities and will absorb an applied liquid formulation including atherapeutic agent differently, resulting in variability in the abilitiesof the tampons to release the therapeutic agent.

Specifically, the need to provide constant agitation or mixing of theformulation including a therapeutic agent poses challenges as to how tokeep a therapeutic agent homogeneously suspended in a solution when theautomated tampon manufacturing process stops. The use of inline mixersand recirculation of the heated liquid formulation during machine stopsmay provide a method to keep the formulation moving and mixed. However,because a machine could be stopped for several hours, the stability ofsome formulation mixtures may be compromised by long durations atelevated temperatures, or by mechanical shear forces due to thecontinuous pumping of the recirculating liquid.

The advantages of using a pre-manufactured delivery tube assembly overan in-line process where the medicated ingredients are applied to thetampon coincident with the tampon manufacturing process are numerous.The delivery tube assembly including a dosage form would be desirablyproduced at a pharmaceutical manufacturer whose manufacturing facilitymeets current regulatory and quality requirements for drugs and/ordevices as appropriate. This could ensure that a therapeutic agent withthe correct dose and purity is dispersed within the dosage form. The useof a delivery tube assembly including a dosage form simplifies themodifications to an existing tampon manufacturing process. The use ofdosage forms allows multiple types of therapeutic agents to be appliedwith the tampon. The chemical and physical stabilities of the dosageform are not compromised by the assembly process with the tampon. Themanufacturing process is less dependent on the physical characteristicsof the absorbent structure of the tampon because the dosage form is notrequired to bond with the tampon.

In addition, environmental conditions, especially during shipping and/orstorage, may cause some formulations including a therapeutic agent tomelt and absorb into the tampon and/or onto the packaging material priorto use, thus making the therapeutic agent less available for use.

The present invention solves these problems by coupling a delivery tubeassembly containing a dosage form to a tampon assembly to form amedicated tampon assembly. The dosage form including a therapeutic agentis solid or semi-solid at room temperature, and is sufficiently stableso that it may be manufactured separately in a controlled facility,whereby the therapeutic agent is easily controlled through controls onhomogeneity, concentration, and purity.

More specifically, the present invention provides a delivery tubeassembly including a delivery tube including a delivery tube attachmentend, a delivery tube second end, an outer surface, and an inner surfacedefining a delivery tube cavity; and a dosage form including atherapeutic agent, wherein the dosage form is positioned within thedelivery tube cavity. The assembly may also include an engagementmechanism positioned at the delivery tube attachment end. The assemblymay also include at least one containment seal. A containment seal iscoupled to the delivery tube second end on the outer surface of thedelivery tube. An inner containment seal may be positioned within thedelivery tube cavity to seal the dosage form within the delivery tubecavity. The containment seals may prevent the dosage form from seepinginto the tampon and/or delivery device packaging should the product beexposed to unacceptable environmental conditions such that the dosageform would begin to melt.

In another aspect, the present invention provides a delivery deviceincluding an applicator having a first member with a receiving end andan insertion end; and a delivery tube assembly affixed to the firstmember at the receiving end by an engagement mechanism.

In another aspect, the present invention provides a kit for treating aphysiological condition, the kit including an applicator and a deliverytube assembly. The delivery tube assembly includes a delivery tubeincluding a delivery tube attachment end, a delivery tube second end atleast partially closed by a plurality of flexible petals, and an innersurface defining a delivery tube cavity, wherein the delivery tube isadapted to be coupled to the applicator at the delivery tube attachmentend. The delivery tube assembly also includes a dosage form, wherein thedosage form is positioned within the delivery tube cavity.

In another aspect, the present invention relates to a method forproviding a delivery device, the method including producing a deliverytube assembly. The delivery tube assembly includes a delivery tubeincluding a delivery tube attachment end, a delivery tube second end atleast partially closed by a plurality of flexible petals having gapstherebetween, an outer surface, and an inner surface defining a deliverytube cavity, wherein the delivery tube is adapted to be coupled to anapplicator at the delivery tube attachment end. The delivery tubeassembly also includes a dosage form including a therapeutic agent,wherein the dosage form is positioned within the delivery tube cavity.The method also includes sealing the delivery tube assembly andpackaging the delivery tube assembly.

In another aspect, the present invention relates to a method forproviding a delivery device, the method including providing a sealeddelivery tube assembly to a consumer. The delivery tube assemblyincludes a delivery tube including a delivery tube attachment end, adelivery tube second end, and an inner surface defining a delivery tubecavity, wherein the delivery tube is adapted to be coupled to anapplicator at the delivery tube attachment end. The delivery tubeassembly also includes a dosage form positioned within the delivery tubecavity. The method also includes instructing the consumer to combine thedelivery tube assembly with an applicator.

The advantages of using a pre-manufactured delivery tube assembly overan in-line process where the medicated ingredients are applied to thetampon coincident with the tampon manufacturing process are numerous.The delivery tube assembly including a dosage form would be desirablyproduced at a pharmaceutical manufacturer whose manufacturing facilitymeets current regulatory and quality requirements for drugs and/ordevices as appropriate. This could ensure that a therapeutic agent withthe correct dose and purity is homogeneously dispersed within the dosageform. The use of a delivery tube assembly including a dosage formsimplifies the modifications to an existing tampon manufacturingprocess. The use of dosage forms allows multiple types of therapeuticagents to be applied with the tampon. The chemical and physicalstabilities of the dosage form are not compromised by the assemblyprocess with the tampon. The manufacturing process is less dependent onthe physical characteristics of the absorbent structure of the tamponbecause the dosage form is not required to bond with the tampon.

The present invention relates to a therapeutic agent delivery systemthat may be integral with or associated with a feminine care product.The therapeutic agent delivery system including the therapeutic agentand excipients may include any therapeutic agent that may be absorbedinto the body through the vaginal or other epithelium, or depositedtopically on the vaginal or other epithelium, for the purposes oftreating a physiological disease, state, or condition.

The present invention relates to a therapeutic agent delivery systemthat may be integral with or associated with a feminine care product.The therapeutic agent delivery system including the therapeutic agentand excipients may include any therapeutic agent that may be absorbedinto the body through the vaginal or other epithelium, or depositedtopically on the vaginal or other epithelium, for the purposes oftreating a physiological disease, state, or condition.

Other objects and advantages of the present invention will become moreapparent to those skilled in the art in view of the followingdescription and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view of a medicated tampon assembly of thepresent invention.

FIG. 2 is an expanded partial cross-sectional view of an engagementmechanism to be used in conjunction with the medicated tampon assemblyof FIG. 1.

FIG. 3 is a cross-sectional view of a delivery tube assembly to be usedin conjunction with the medicated tampon assembly of FIG. 1.

FIG. 4 is a partial perspective view of another aspect of an engagementmechanism for the medicated tampon assembly of FIG. 1.

FIG. 5 is a partial perspective view of another aspect of an engagementmechanism for the medicated tampon assembly of FIG. 1.

FIG. 6 is a partial perspective view of another aspect of a deliverytube for the medicated tampon assembly of FIG. 1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention as described herein will be described for exemplarypurposes using a tampon as an example of a feminine care product. Theinvention, however, applies equally to other forms of products,including tampon-like devices and vaginally- and anally-inserteddevices, and should not be limited to the example described herein. Inaddition, although the example described includes a tampon withabsorbent material, a product without absorbent material, such as atampon applicator or other similar applicator, is also contemplatedwithin the invention. Also contemplated is the use of the presentinvention in conjunction with non-catamenial feminine products such asincontinence products, including female incontinence inserts.

The term “surface” and its plural generally refer herein to the outer orthe topmost boundary of an object.

The term “dosage form” is used herein as a generic term for a unit formof a formulation that includes a therapeutic agent. The dosage formincludes a discrete and consistent quantity of the therapeutic agent toallow for consistent dosing of one receiving the dosage form. The dosageform may be a suppository, a capsule, a tablet, a gel, or any othersuitable form. The dosage form may also be spherical, ovoid, domal,generally flat, or any other suitable shape dictated by the needs of theapplication of the dosage form. The dosage form may have convex,concave, planar, arcuate, or any other suitable surfaces as dictated bythe needs of the application of the dosage form.

FIG. 1 illustrates a delivery device in the form of a medicated tamponassembly 10 that includes a tampon assembly 40 and a delivery tubeassembly 50. The tampon assembly 40 includes a tampon applicator 12 witha first member 14 and a second member 18, where the tampon applicator 12is designed to house a catamenial tampon 20 and provide a comfortablemeans of inserting the tampon 20 into a woman's vagina. The deliverytube assembly 50 is designed to attach to the first member 14, as isdescribed in more detail below. In another aspect of the presentinvention, the tampon assembly 40 or the tampon applicator 12 may bereferred to simply as an applicator, particularly if the tampon assembly40 does not include a tampon 20, or if the tampon applicator 12 is notassociated with a tampon 20.

The tampon applicator 12 includes a first member 14 and a second member18. The first member 14 may be in the form of a spirally wound,convolutely wound or longitudinally seamed hollow tube which is formedfrom paper, paperboard, cardboard, plastic, other suitable material, ora combination of such materials. Any plastic in the first member 14 ispreferably polyethylene, but may be polypropylene or other suitableplastic. The first member 14, also commonly referred to as an outertube, may be of any suitable dimensions necessary to house a particularsize of tampon 20. The first member 14 has a wall 22 with an outside orexterior surface 24.

The first member 14 is sized and configured to house the absorbenttampon 20, and should have a substantially smooth exterior surface 24which will facilitate insertion of the first member 14 into a woman'svagina. When the exterior surface 24 is smooth and/or slippery, thefirst member 14 will easily slide into a woman's vagina withoutsubjecting the internal tissues of the vagina to abrasion. The firstmember 14 may be coated to give it a high slip characteristic. Wax,polyethylene, a combination of wax and polyethylene, cellophane and clayare representative coatings that may be applied to the first member 14to facilitate comfortable insertion. The first member 14 itself may beformulated to give it a high slip characteristic, including the additionof additives to the resin from which the first member is made, or by analteration in physical structure of the exterior surface 24, such asadding pebbling or other bumps, to decrease the amount of surface areain contact with the vaginal or other epithelium.

Referring to FIG. 1, the first member 14 has an insertion end 26 and areceiving end 30. The insertion end 26 is shown having a plurality ofpleats or petals 27 that may radially open such that the insertion end26 has a diameter approximately equal to the diameter of the firstmember 14. The petals 27 may be either even or odd in number and may beequally spaced apart or non-uniformly arranged.

In another aspect of the present invention that is not shown, theinsertion end 26 may be configured without petals 27, such that itsimply has an opening of a diameter approximately equal to the diameterof the first member 14.

As stated above, the medicated tampon assembly 10 includes a secondmember 18, also commonly referred to as an inner tube. The second member18 has a free end 31. The second member 18, like the first member 14,may be a spirally wound, a convolutely wound or a longitudinally seamedhollow tube constructed from paper, paperboard, cardboard, plastic,other suitable material, or a combination of these materials. The secondmember 18 may be constructed of the same material as the first member 14or it may be made out of a different material. The second member 18 mayalso be a solid stick or use some other unique shape. It is alsopossible to form a finger flange 32 on the free end 31 of the secondmember 18 to provide an enlarged surface onto which the user'sforefinger may rest. The finger flange 32 thereby functions as a seatfor the forefinger and facilitates movement of the second member 18 intothe first member 14.

Referring again to FIG. 1, the first member 14 may have a fingergripring 28 located proximate the receiving end 30. The fingergrip ring 28provides an enlarged surface onto which one or more fingers of the usermay rest. In use, the user may position one or more fingers on thefingergrip ring 28 and one or more fingers on the finger flange 32. Theuser then holds the fingergrip ring 28 and pushes the finger flange 32to move the second member 18 toward and into the first member 14.

Referring to FIGS. 1 and 2, the receiving end 30 of the first member 14has part of an engagement mechanism 76 (described in more detail below)to facilitate attachment of the delivery tube assembly 50 to the firstmember 14.

Referring again to FIG. 1, the tampon 20 has an absorbent memberprimarily designed to be worn by a woman during her menstrual period toabsorb menses and other body fluids. The tampon 20 includes a tamponbody 34 and a withdrawal string (not shown). The tampon body 34 isnormally compressed into the form of a cylinder and may have a blunt,rounded or shaped forward end. The tampon body 34 has a forward ordistal end 38 that is closer to the cervix when the tampon 20 is in use.The tampon body 34 also has a proximal end 39 that is closer to thevaginal opening when the tampon 20 is in use. The tampon 20 commonly hasa withdrawal string fastened to the tampon body 34 and extending fromthe proximal end 39. The withdrawal string serves as a means forwithdrawing the tampon 20 from the woman's vagina. Catamenial tamponssuitable for use in the present invention include an absorbent materialas is known in the art. The distal end 38 of the tampon body 34 or thetampon body 34 itself may be formed into specific shapes such as variouscup shapes to enhance the therapeutic agent contact area with thecervix, anterior fornix, posterior fornix, lateral fornices, vaginalepithelium areas, or conformance to other anatomical areas within thevaginal or other cavity.

In another aspect of the present invention (not shown), the tamponapplicator 12 may be produced without a tampon 20. Such a configurationis similar to that described above.

Referring to FIGS. 1 and 3, the delivery tube assembly 50 includes adelivery tube 60 with an attachment end 62 and an open delivery tubesecond end 64. The delivery tube 60 may have a delivery tube ring 63 atthe attachment end 62. The delivery tube 60 may include a plurality ofpleats or petals 66 at and partially closing the delivery tube secondend 64. The petals 66 may radially open such that the delivery tubesecond end 64 of the delivery tube 60 has a diameter approximately equalto the diameter of the delivery tube 60. The petals 66 may be eithereven or odd in number and may be equally spaced apart or non-uniformlyarranged. Between any two petals 66 is a gap 68 that provides additionalflexibility to the petals 66. As shown in FIG. 6, and in another aspectof the present invention, the gaps 68 may be filled by a frangibleportion 69 such that the delivery tube second end 64 is closed by petals66 and frangible portions 69 until force applied by the dosage form 45,the tampon 20, or the second member 18 causes the frangible portions 69to break, allowing the petals 66 to open.

The delivery tube 60 also includes a delivery tube outer surface 70 anda delivery tube inner surface 72, where the delivery tube inner surface72 defines and at least partially encloses a delivery tube cavity 74.The delivery tube 60 is preferably manufactured from material similar tothat of the first member 14, but any suitable material may be used.

The delivery tube 60 is sized and configured to house the first member14, and the delivery tube outer surface 70 should be substantiallysmooth to facilitate insertion of the delivery tube 60 into a woman'svagina. When the delivery tube outer surface 70 is smooth and/orslippery, the delivery tube 60 will easily slide into a woman's vaginawithout subjecting the internal tissues of the vagina to abrasion. Thedelivery tube 60 may be coated to give it a high slip characteristic.Wax, polyethylene, a combination of wax and polyethylene, cellophane andclay are representative coatings that may be applied to the deliverytube 60 to facilitate comfortable insertion. The delivery tube 60 itselfmay be formulated to give it a high slip characteristic, including theaddition of additives to the resin from which the first member is made,or by an alteration in physical structure of the delivery tube outersurface 70, such as adding pebbling or other bumps, to decrease theamount of surface area in contact with the vaginal or other epithelium.

The attachment end 62 of the delivery tube 60 includes an engagementmechanism 76 (shown in FIGS. 2-5) that allows the delivery tube 60 to beattached to the first member 14 with minimal force. The attachmentprovided by the engagement mechanism 76 is preferably one-way orpermanent for the improved structural integrity of the delivery tube 60with the first member 14 in use. In most types of engagement mechanismssuitably applied in such an application, the engagement mechanism 76typically includes a first portion 77 and a second portion 78, where thefirst portion 77 engages with the second portion 78 to complete theengagement mechanism 76. The first portion 77 is positioned on one ofthe delivery tube 60 or the first member 14, and the second member 78 ispositioned on the other of the delivery tube 60 or the first member 14.The engagement mechanism 76 may be any suitable mechanism, including,but not limited, to a snap ring, conventional screw threads,quarter-turn threads, a mechanical latch, and an escapement-typemechanism.

The engagement mechanism 76 between the delivery tube 60 and the firstmember 14 are shown in FIG. 2 as having a snap-on engagement profile.Such a profile is convenient to manufacture, may be assembled withminimal force, and creates the one-way attachment preferred for thestructural integrity of this product. In one aspect of an engagementmechanism 76 of the present invention, the delivery tube 60 is designedto engage with the fingergrip ring 28 of the first member 14, as shownin FIG. 2. The delivery tube 60 includes an indent 75 that snaps aroundand accommodates the fingergrip ring 28. The engagement mechanism 76 maybe configured to provide an audible click and a tactile sensation tosignal that the delivery tube 60 is properly in place with respect tothe first member 14.

In an example of a screw-type engagement mechanism 176 illustrated inFIG. 4, the delivery tube 60 includes a first portion 177 includinghelically-positioned projections 179, and the first member 14 includes asecond portion 178 including helically-positioned projection-receivingspaces 181. The delivery tube 60 is moved toward and twisted onto thefirst member 14 such that the helically-positioned projections 179engage or interlock with the projection-receiving spaces 181. In anotheraspect of this example (not shown), the first portion 177 includinghelically-positioned projections 179 is positioned on the first member14, and the second portion 178 including helically-positionedprojection-receiving spaces 181 is positioned on the delivery tube 60.

In an example of a quarter-turn-type engagement mechanism 276illustrated in FIG. 5, the delivery tube 60 includes a first portion 277including a helically-positioned projection 279, and the first member 14includes a second portion 278 including a helically-positionedprojection-receiving space 281. The delivery tube 60 is moved toward andtwisted onto the first member 14 such that the helically-positionedprojection 279 engages or interlocks with the projection-receiving space281. In another aspect of this example (not shown), the first portion277 including a helically-positioned projection 279 is positioned on thefirst member 14, and the second portion 278 including ahelically-positioned projection-receiving space 281 is positioned on thedelivery tube 60.

In another aspect of the present invention, the engagement mechanism 76may include an aligning mechanism (not shown) to ensure that thedelivery tube assembly 50 is particularly aligned, as desirable, withthe first member 14 when the two are combined to form the medicatedtampon assembly 10. The aligning mechanism may be a keyway or any othersuitable aligning mechanism.

Referring to FIGS. 1 and 3, the delivery tube assembly 50 includes adosage form 45 positioned within the delivery tube assembly 50. Thedosage form 45 is positioned within the delivery tube cavity 74 and maybe shaped to generally conform to the inner surface 72 of the deliverytube 60. In other aspects of the present invention, any other suitableshape for the dosage form 45 may be used. The dosage form 45 may beformed directly within the delivery tube cavity 74 by depositing aformulation including a therapeutic agent directly into the deliverytube cavity 74. Alternatively, the dosage form 45 may also bepre-manufactured in the same or separate facility and then placed withinthe delivery tube cavity 74 during manufacture of the delivery tubeassembly 50. Further detail concerning the manufacture of dosage forms45 is disclosed in co-pending U.S. patent application Ser. No.10/335,816 filed on Dec. 31, 2002 and titled “Medicated Tampon”.

In one aspect of the present invention, the dosage form 45 may beproduced in any suitable form including, but not limited to, tablets,capsules, suppositories, gels, disks, lozenges, films, coatings, andother forms. In an alternate aspect of the present invention, the dosageform 45 may be produced in encapsulated form.

In another aspect of the present invention, the tablet, suppository, orcapsule may be designed to melt at approximately body temperature, or todissolve or otherwise disperse in the presence of a sufficient aqueousor other liquid trigger, or appropriate chemistry, such as a suitablepH.

In an additional aspect of the present invention, the dosage form 45 maybe formed in any shape to promote contact with anatomical structuressuch as the vaginal epithelium, the anterior fornix, the posteriorfornix, the lateral fornices, the cervix, or other structures.

The dosage form 45 may include any therapeutic agent, along with anyexcipients, compounds, or other ingredients that are desirable tointroduce into the vaginal or other cavity to promote the functionalityof that therapeutic agent. The excipients may assist the release of thetherapeutic agent, or assist in the absorbency of the therapeutic agentinto the vaginal or other epithelium. The use of excipients tofacilitate the formulation, delivery, stability, and aestheticproperties of a therapeutic agent delivery system is well known to thosefamiliar with the art. Examples of ingredients that may accompany thetherapeutic agent in the dosage form 45 include excipients,biologically-compatible adhesives, surfactants, and penetrationenhancers. An example of a suitable excipient is SUPPOCIRE suppositorybase, available from Gattefossé Corp. SUPPOCIRE suppository base is asemi-synthetic glyceride. An example of a suitablebiologically-compatible adhesive is hydroxypropyl methylcellulose(HPMC), available as METHOCEL* K15M from The Dow Chemical Company. Anexample of a suitable surfactant is polysorbate 80, available fromSpectrum Chemical Manufacturing Corp. An example of a suitablepenetration enhancer is LABRAFIL M 1944 C nonionic amphiphilicexcipient, available from Gattefossé Corp.

For the purposes of this invention, any therapeutic agent that willtreat the vaginal or other cavity, other mucosal tissue, or will beabsorbed into a user's body through the vaginal or other epithelium forthe purposes of treating diseases or conditions, promoting the growth ofnormal vaginal bacterial flora, or promoting vaginal health may be used.Examples of therapeutic agents include but are not limited to vitamins,minerals, hormones, moisturizers, antifungal agents, antibacterialagents, pro-biotics, botanicals, analgesics, prostaglandin inhibitors,prostaglandin synthetase inhibitors, leukotriene receptor antagonists,essential fatty acids, sterols, anti-inflammatory agents, vasodilators,chemotherapeutic agents, and agents to treat infertility.

Some therapeutic agents for use in this invention are absorbable throughthe vaginal epithelium and travel to the uterus by a unique portal ofveins and arteries that are known to exist between the vagina, thecervix, and the uterus. This anastomosis eliminates first-passmetabolism by the liver, effectively delivering higher concentrations ofthe therapeutic agent to the uterus than would otherwise be availablevia oral dosing. Those of skill in the art know the efficacy of varioustherapeutic agents when introduced at a particular anatomical location.For example, when the therapeutic agent is selected to treatdysmenorrhea, it preferably is selected from the following group:nonsteroidal anti-inflammatory drugs (NSAIDs), prostaglandin inhibitors,COX-2 inhibitors, local anesthetics, calcium channel blockers, potassiumchannel blockers, β-adrenergic agonists, leukotriene blocking agents,smooth muscle inhibitors, and drugs capable of inhibiting dyskineticmuscle contraction.

Alternatively therapeutic agents modify the vaginal or other environmentto enhance the wellness of this anatomical region. The benefits may berather simple, for example increasing comfort by providingmoisturization and/or lubricity. These benefits may also be morecomplex, for example modulating epithelial cell function to addressvaginal atrophy. The beneficial therapeutic agents may reduce negativesensations such as stinging, burning, itching, etc, or introducepositive sensations to improve comfort.

Referring to FIG. 3, the delivery tube assembly 50 may also include acontainment seal 110 to seal the dosage form 45 within the delivery tubecavity 74. The containment seal 110 may be removable using pull tab 111,as shown in FIG. 3.

As shown in FIG. 3, the containment seal 110 may be positioned at thedelivery tube second end 64 of the delivery tube 60 such that thecontainment seal 110 extends sufficiently to seal the gaps 68 betweenthe petals 66. The containment seal 110 is affixed to the delivery tube60 at the delivery tube second end 64 using any suitable adhesive oraffixing means, including the use of hot-melt, water-based,solvent-based, or pressure-sensitive adhesives, mucilage, a thermalseal, ultrasonic bonding, pressure, friction, electrostatics, cling-likepoly wraps, or surface energy effects that will not adversely interactwith the dosage form. The containment seal 110 remains affixed duringshipping and handling, but may be removed by a manufacturer or aconsumer to reveal the contents of the delivery tube 60. The containmentseal 110 may be durable. In another aspect of the present invention, thecontainment seal 110 may be left in place during use and may melt ordissolve in the body. The containment seal 110 may be formed from anysuitable material, including foil, poly, film, film laminates,nonwovens, nonwoven laminates, protective materials such as TYVEKprotective material, and any suitable elastomeric substance includingrubber, or by a combination of these materials that will not adverselyinteract with the dosage form. The containment seal 110 may also beconfigured to tear along perforations or frangible sections underpressure, allowing the dosage form 45 and optionally a tampon 20 to beexpelled.

In addition, and referring to FIGS. 3-6, the delivery tube assembly 50may also include an inner containment seal 112 to seal the dosage form45 within the delivery tube cavity 74. The inner containment seal 112may be removable, or may be frangible. If the inner containment seal 112is removable, the inner containment seal 112 may have attached to it apull-tab 113 positioned such that pulling the pull-tab 113 from thedelivery tube assembly 50 will result in pulling the inner containmentseal 112 from the delivery tube assembly 50 as well.

As shown in FIG. 3, the inner containment seal 112 may be positionedwithin the delivery tube cavity 74 such that the inner containment seal112 extends across the diameter of the delivery tube 60, contacting andbeing affixed to the inner surface 72 of the delivery tube 60 in amanner sufficient to seal the dosage form 45 within the delivery tubecavity 74. The inner containment seal 112 is shown in FIG. 3 to beadjacent the dosage form 45, but may be positioned at any point withinthe delivery tube cavity 74. The inner containment seal 112 is affixedto the inner surface 72 of the delivery tube 60 using any suitableadhesive or affixing means, including the use of hot-melt, water-based,solvent-based, or pressure-sensitive adhesives, mucilage, a thermalseal, ultrasonic bonding, pressure, friction, electrostatics, cling-likepoly wraps, or surface energy effects that will not adversely interactwith the dosage form. The inner containment seal 112 remains affixedduring shipping and handling, but may be removed by a manufacturer or aconsumer to reveal the contents of the delivery tube 60. The innercontainment seal 112 may be durable or may melt or dissolve in the body.The inner containment seal 112 may be formed from any suitable material,including foil, poly, film, film laminates, nonwovens, nonwovenlaminates, protective materials such as TYVEK protective material, andany suitable elastomeric substance including rubber, or by a combinationof these materials that will not adversely interact with the dosageform.

The inner containment seal 112 may also be frangible and remain in placeduring use. In this aspect, the frangible inner containment seal 112remains in place when the delivery tube 60 is attached to the firstmember 14 to create the medicated tampon assembly 10. The frangibleinner containment seal 112 includes a frangible or breakaway portionwith break lines (not shown) allowing the inner containment seal 112 tobreak into sections while each section remains attached to the deliverytube 60. In one aspect of the present invention, the break lines arealong the inner surface 72 of the delivery tube 60, allowing the innercontainment seal 112 to be released from the delivery tube 60. Thefrangible inner containment seal 112 may be formed from any suitablematerial, including foil, poly, film, film laminates, nonwovens,nonwoven laminates, TYVEK protective material, and any suitableelastomeric substance including rubber, or by a combination of thesematerials that will not adversely interact with the dosage form.

Returning to FIG. 1, in one embodiment of the present invention thedelivery tube assembly 50 including the dosage form 45 and the tamponassembly 40 are combined to form the medicated tampon assembly 10. Adelivery tube assembly 50 including a dosage form 45 is axially alignedwith a tampon assembly 40. The delivery tube assembly 50 and the tamponassembly 40 are moved toward each other using minimal force to cause theengagement mechanism 76 of the delivery tube assembly 50 and the firstmember 14 to engage, resulting in the delivery tube 60 becomingpermanently attached to the first member 14. The medicated tamponassembly 10 may then be packaged and shipped. Alternatively, the tamponassembly 40 and the delivery tube assembly 50 with dosage form 45 may bepackaged separately and shipped together or separately. These may laterbe combined by an assembler or a consumer.

More specifically, the various components of the medicated tamponassembly 10 may be manufactured and assembled in a variety of ways, butgenerally focus on three subassemblies: the tampon assembly 40, thedelivery tube assembly 50, and the dosage form 45.

The dosage form 45 may be produced by the same manufacturer as themanufacturer of the tampon assembly 40. The dosage form 45 may also beproduced by a separate manufacturer and provided to the tamponmanufacturer in any suitable manner. In another aspect of the presentinvention, the tampon assembly 40 may be produced by a manufacturerdifferent from the manufacturer of the delivery tube assembly 50 andboth assemblies (40, 50) may be shipped to the manufacturer of thedosage form 45 for manufacture of the medicated tampon assembly 10. Inanother aspect of the present invention, the medicated tampon assembly10 is produced by a manufacturer different from the manufacturer of thedosage form 45, the manufacturer of the tampon assembly 40, and themanufacturer of the delivery tube assembly 50.

As an example, a dosage form manufacturer with a facility specificallydesigned for pharmaceutical manufacturing that meets current regulatoryand quality requirements for drugs and/or devices, as appropriate, mayproduce the dosage form 45 under conditions such that homogeneity,concentration, and purity of the dosage form 45 are closely controlled,and such that production is in accordance with applicable regulations.The dosage form 45 may then be sealed and shipped to the manufacturer ofeither the tampon assembly 40 or the delivery tube assembly 50. In thismanner, the dosage form 45 is produced by a manufacturer withappropriate experience, and the tampon manufacturer may be relieved ofestablishing a pharmaceutical-production facility. This process isdescribed in more detail in co-pending U.S. patent application Ser. No.10/335,816 filed on Dec. 31, 2002 and titled “Medicated Tampon”.

Likewise, the delivery tube assembly 50 including a dosage form 45 maybe produced by the same manufacturer as the manufacturer of the tamponassembly 40. The delivery tube assembly 50 including a dosage form 45may also be produced by a separate manufacturer and provided to thetampon manufacturer in any suitable manner. As an example, apharmaceutical manufacturer with a facility specifically designed forpharmaceutical manufacturing that meets current regulatory and qualityrequirements for drugs and/or devices, as appropriate, may producedelivery tube assemblies 50 including dosage forms 45 under conditionssuch that homogeneity, concentration, and purity of the dosage form 45are closely controlled, and such that production is in accordance withapplicable regulations. The delivery tube assembly 50 including thedosage form 45 may then be sealed and shipped to the tamponmanufacturer. The tampon manufacturer may then apply the delivery tubeassembly 50 including a dosage form 45 to a tampon assembly 40 underappropriately-controlled conditions. In this manner, the delivery tubeassembly 50 with a dosage form 45 is produced by a manufacturer withappropriate experience, and the tampon manufacturer is relieved ofestablishing a pharmaceutical-production facility.

In any case, the dosage form 45, the delivery tube assembly 50, and thetampon assembly 40 are each manufactured. The dosage form 45 anddelivery tube assembly 50 are combined and sealed if appropriate, andthen the delivery tube assembly 50 (with dosage form 45) is combinedwith a tampon assembly 40, by either a manufacturer or by a consumer.

In a different aspect of the present invention, the tampon assembly 40and the delivery tube assembly 50 with dosage form 45 may be packagedseparately. Both may then be provided to a consumer, either separatelyor in one package or kit. The consumer may also obtain the delivery tubeassembly 50 and the tampon assembly 40 from separate manufacturers. Ineither case, either assembly may include instructions for use of amedicated tampon assembly 10. Such instructions may include informationregarding when a medicated tampon assembly 10 is appropriate to use,standard pharmaceutical information regarding the dosage form 45 andtherapeutic agent(s) contained in the dosage form 45, and directionsregarding the method for properly combining the delivery tube assembly50 and the tampon assembly 40. The consumer Will be instructed to removeboth a tampon assembly 40 and a delivery tube assembly 50 from theirpackaging. The consumer will then remove the inner containment seal 112from the delivery tube assembly 50 if a removable inner containment seal112 is present. The consumer will then be instructed to attach thedelivery tube assembly 50 to the tampon assembly 40 by whatever methodis appropriate for the type of engagement mechanism 76 that is presentsuch that the delivery tube 60 becomes engaged with the tampon assembly40. Finally, the consumer will be instructed to remove the containmentseal 110 from the medicated tampon assembly 10 and use the medicatedtampon assembly 10 as one would use a standard tampon.

In a different aspect of the present invention, a consumer may beprovided with a delivery tube assembly 50 including a dosage form 45,along with a tampon assembly 40 that does not include a tampon 20. Theassembly and use in this case will be similar to that of the completemedicated tampon assembly 10, but the consumer will be using the dosageform 45 alone without the tampon 20.

In use, and referring to FIG. 1, the medicated tampon assembly 10functions because the second member 18 is telescopically movablerelative to the first member 14. As the second member 18 is pushed intothe first member 14, the tampon 20, if one is present, or the secondmember 18, if a tampon 20 is not present, is forced forward against thedosage form 45, which is thereby forced against the delivery tube petals66. The contact by the dosage form 45 causes the delivery tube petals 66to radially open to a diameter that is sufficient to allow the dosageform 45 and the tampon 20, if one is present, to be expelled from thefirst member 14. With the dosage form 45 and the tampon 20, if one ispresent, properly positioned in the vaginal or other cavity, the tamponapplicator 12 is withdrawn and properly discarded.

Referring to FIG. 3, in the case where the delivery tube assembly 50includes a frangible inner containment seal 112, as the second member 18is pushed into the first member 14, the tampon 20, if one is present, orthe second member 18, if a tampon 20 is not present, is forced forwardagainst the frangible inner containment seal 112, causing the frangibleinner containment seal 112 to break to allow the tampon 20, if one ispresent, or the second member 18, if a tampon 20 is not present, to passthrough unimpeded. The tampon 20, if one is present, or the secondmember 18, if a tampon 20 is not present, is then forced forward againstthe dosage form 45, which is thereby forced against the petals 66. Thecontact by the dosage form 45 causes the petals 66 to radially open to adiameter that is sufficient to allow the dosage form 45 to be expelledfrom the delivery tube 60 and the tampon 20, if one is present, to beexpelled from the first member 14 and the delivery tube 60. Again, withthe dosage form 45 and the tampon 20, if one is present, properlypositioned in the vaginal or other cavity, the tampon applicator 12 withthe attached delivery tube 60 is withdrawn and properly discarded.

Finally, in the case where the first member 14 includes petals 27, asthe second member 18 is pushed into the first member 14, the tampon 20,if one is present, or the second member 18, if a tampon 20 is notpresent, is forced forward against the petals 27. The petals 27 bend toallow the tampon 20, if one is present, or the second member 18, if atampon 20 is not present, to pass through unimpeded. The tampon 20, ifone is present, or the second member 18, if a tampon 20 is not present,is then forced forward against the frangible inner containment seal 112,if one is present, as described above, and then against the dosage form45, which is thereby forced against the petals 66. The contact by thedosage form 45 causes the petals 66 to radially open to a diameter thatis sufficient to allow the dosage form 45 and the tampon 20, if one ispresent, to be expelled from the first member 14. Again, with the dosageform 45 and the tampon 20, if one is present, properly positioned in thevaginal or other cavity, the tampon applicator 12 with the attacheddelivery tube 60 is withdrawn and properly discarded.

Once the tampon 20 is properly positioned in the vaginal or othercavity, the tampon body 34 absorbs menses and other bodily fluids, andthe dosage form 45 delivers the therapeutic agent to the vaginal orother epithelium for local or topical therapeutic action or from there,the therapeutic agent may be transferred to the uterus by normal bodilyfunctions to relieve the condition to be treated.

The invention has been described with reference to various specific andillustrative aspects and techniques. However, it should be understoodthat many variations and modifications may be made while remainingwithin the spirit and scope of the invention.

Accordingly, this invention is intended to embrace all suchalternatives, modifications and variations that fall within the spiritand scope of the appended claims.

1. A delivery tube assembly for use in conjunction with a tamponapplicator having a first member with a tampon therein and a secondmember, the delivery tube assembly comprising: a delivery tubecomprising a delivery tube attachment end, an open delivery tube secondend opposite the delivery tube attachment end, an outer surface, and aninner surface defining a delivery tube cavity; and a dosage formincluding a therapeutic agent, wherein the dosage form is positionedwithin the delivery tube cavity wherein the first member and the secondmember are separate and distinct from the delivery tube; and wherein thedelivery tube completely covers the first member so that it is notvisible to a user.
 2. The assembly of claim 1, wherein the delivery tubeis adapted to be coupled to the tampon applicator at the delivery tubeattachment end.
 3. The assembly of claim 1, wherein the delivery tubeincludes means for attaching the delivery tube to the tampon applicator.4. The assembly of claim 1, further comprising an engagement mechanismpositioned at the delivery tube attachment end.
 5. The assembly of claim4, wherein the engagement mechanism is selected from a group consistingof a snap ring, a screw mechanism, quarter-turn threads, a mechanicallatch, and an escapement-type mechanism.
 6. The assembly of claim 1,further comprising an inner containment seal positioned within thedelivery tube cavity to seal the dosage form within the delivery tubecavity.
 7. The assembly of claim 6, wherein the inner containment sealis removable.
 8. The assembly of claim 7, wherein the inner containmentseal is frangible.
 9. The assembly of claim 1, wherein the dosage formconforms to the inner surface within the delivery tube cavity.